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Historic, Archive Document Do not assume content reflects current scientific knowledge, policies, or practices. or- = _ |S = a_m d2i-3e a 7. - a, EVOINCIO AICIn ee sO Kealietl! Fiscal Year 1992 Report of the Secretary of ee =f, 4 Agriculture to the President pelt of the Senate area lyts Ree ecmS tell =, and the Speaker adel Sas: é of the House of Representatives O“2S. .S eP he “al y I= ff *— _ il<." = oloite s at er: af"eLp s=a ! “yee %p1,!o pe a venNA United States Animal and APHIS 41-35-020 Department of Plant Health Agriculture Inspection Noas(ae The programs of the U.S. Department of Agriculture are available to anyone without regard to race, color, creed, sex, disability, religion, or national origin. Issued June 1993 Contents Report of 1992 Activities 2 Summary 2 Animal Welfare Accomplishments for FY 1992 3 Legislative History 4 Regulations 4 Expenditures for FY 1992 4 Organization and Administration of the AWA 5 APHIS/REAC Headquarters Activities 5 APHIS/REAC Field Activities 5 Training 5 Licensing and Registration 6 Research Facilities 6 Reports From Research Facilities 7 Animal Exhibitors 8 Carriers and Intermediate Handlers 9 Licensed Dealers 10 Summary of Inspections 11 Prelicensing Inspections 11 Compliance Inspections 11 Inspections of Animals in Transit 11 Complaints 12 Violations and Investigations 12 Liaison With Other Federal Agencies 12 Other Activities 13 Public Information 13 Public Correspondence 13 Freedom of Information Act (FOIA) Requests 13 Legislative Recommendations 13 Glossary of Terms 14 Appendix Table 1. Number of Licensees and Registrants 15 Table 2. Animals Used in Experimentation 16 Table 3. Animals Used in Experimentation No Pain—No drugs 17 Table 4. Animals Used in Experimentation, With Pain—With Drugs 18 Table 5. Animals Used in Experimentation, With Pain—No Drugs 19 Attachments Animal Welfare: List of Licensed Dealers Animal Welfare: List ofR egistered Research Facilities Animal Welfare: List of Licensed Exhibitors Animal Welfare: List of Registered Exhibitors Animal Welfare: List of Registered Carriers and Intermediate Handlers Report of 1992 Activities Each year, the Secretary of Agriculture reports on adminis- inspections per site in FY 1992 increased to 1.87, com- tration and enforcement activities of the Animal Welfare pared to 1.40 in FY 1991’. Also in FY 1992, the number of Act (AWA) (7 U.S.C. 2131 et seq.) as required by Section investigations of violators conducted, cases submitted, 25 of the AWA. Furthermore, Section 25 states that: cases resolved, and sanctions imposed all increased “(Ohis report as well as any supporting documents, data, significantly. or findings shall not be released to any other persons, non-Federal agencies, or organizations unless and until it In FY 1992, APHIS/REAC continued its efforts to increase has been made public by an appropriate committee of the the quality of inspection by presenting 6 training courses Senate or the House of Representatives.” to 196 participants. The number of field inspectors (veterinary medical officers and animal care inspectors) The present report covers fiscal year (FY) 1992, which remained constant at 86. began October 1, 1991, and ended September 30, 1992. The data in this publication indicate that the Animal Care Summary unit of REAC is continually improving the overall efficiency of the inspection force. The FY 1992 Animal Welfare Program had essentially the same budget as in FY 1991. However, the Animal and The following tabulations and charts 1 and 2 graphically Plant Health Inspection Service (APHIS), Regulatory show FY 1992 APHIS/REAC accomplishments. Enforcement and Animal Care (REAC) unit increased inspections by 29 percent. REAC field personnel con- 'Carrier inspections are not included in this number because the total number of ducted 17,764 compliance inspections and reinspections sites is in the thousands and varies greatly from year to year. Prelicensing (which does not include prelicensing and carrier inspec- inspections are excluded because they are not compliance inspections. tions!) at 9,483 facilities and sites. With the addition of *In the FY 1991 Animal Welfare Enforcement report, carrier inspection numbers were accidentally included in this category. The adjusted site inspection rate prelicensing and carrier inspections, the total number of should be 1.40 instead of the 1.54 reported. inspections increased to 22,827, or 27 percent over that of FY 1991 (18,003). Furthermore, the average number of Chart 1 Animal Welfare Accomplishments rif esis 25,000 20,000 15,000 10,000 5,000 2.855 3,022 247 245 338 Ni Dealer Research Exhibitor In transit In transit Prelicensing inspections inspections inspections carriers handlers inspections Results from Work-Based Budget System (WBBS) reports Animal Welfare Accomplishments for FY 1992 : Percent Percent : Inspection increase in Inspection increase in Number of rate per Number of inspections Number of rate per Number of inspections sites site inspections from FY 1991 sites site inspections from FY 1991 Compliance Inspections! Those Inspections Not Included in the Calculations for Compliance Inspection Dealers 4,324 2.16 9,337 36 In transit Research carriers 2136 NA 2,041 47 facilities 3,205 iow 4,839 Pal Prelicensing inspections NA NA 3,022 6 Exhibitors 13672 1.94 o200) 23 In transit handlers 282 1220 338 38 Total of All Inspections Totals 9,483 IS 17,764 29 Overall totals — — 22,02) 27 'The total compliance inspections do not include prelicensing and carrier inspection. Prelicensing inspections are “announced” inspections. Compliance inspections are “unannounced” inspections/reinspections. Because the number “Transportation Carrier Sites is a category representing commercial airlines. Each of carrier sites can be in the thousands and varies greatly from year to year, their airline may have two or more animal transportation “sites” at each airport it inspections are not calculated into the total compliance inspections. serves. Due to frequent changes in airline activities and other factors, the number of sites is constantly changing. REAC inspectors concentrate most of their efforts on major airports. Chart 2 Compliance Inspections FY 1990-92 Dealers Research Exhibitors Intermediate facilities handlers Results from WBBS reports Number of compliance inspections made during Regulations FY, 1990-92: The Improved Standards for Laboratory Animals Act was passed as part of the Food Security Act of 1985 (Public Total Site facilities Total inspection Law 99-198). That law amended the AWA and required FY) (sites) inspections! rate the Secretary of Agriculture to promulgate standards for the exercise of dogs and for a physical environment adequate 1992 Weil 117,764 1.87 to promote the psychological well-being of nonhuman (9,483) primates. Additional requirements of the 1985 amendments included the establishment of Institutional Animal 1991 7,811 139/62 1.40 Care and Use Committees at research facilities; standards to (9,832) ensure that pain and distress are minimized and that anesthetics, analgesics, and tranquilizers are used appropri- 1990 2D "13,050 1.40 ately; and standards that require a researcher to consider (9,319) alternatives to painful procedures. In order to implement the Improved Standards for Laboratory Animals Act, the final regulations for Parts 1 and 2 were published on 'Total calculated numbers and rates do not include prelicensing or carrier inspections. Because they are “announced” inspections, prelicensing inspections August 31, 1989; those for Part 3 were published on are not considered compliance inspections. Carrier inspections are not included February 15, 1991. because the number of sites varies greatly from year to year. *In the FY 1991 Animal Welfare Enforcement report, carrier inspection numbers were accidentally included in this category. The correct inspection number is Revised standards for guinea pigs, hamsters, and rabbits 13,762. The site inspection rate should be 1.40 instead of the 1.54 reported in were published in final form in the Federal Register on lee ONL, July 15, 1990, and became effective on August 15, 1990. These standards increased the minimum space require- Legislative History ments and provided additional requirements to protect animals being transported via common carrier. In 1966, Congress enacted Public Law 89-544, known as the Laboratory Animal Welfare Act. This law regulated On April 5, 1990, USDA/APHIS published a notice in the dealers who handle dogs and cats, as well as laboratories Federal Register of its intent to regulate horses used for that use dogs, cats, hamsters, guinea pigs, rabbits, and biomedical or other nonagricultural research, and other nonhuman primates in research. farm animals used for biomedical or other nonagricultural research or for nonagricultural exhibition. The final rule The first amendment to the Laboratory Animal Welfare Act became effective on June 4, 1990. Until specific regula- was passed in 1970 (P.L. 91-579) and changed the name of tions can be promulgated, the-standards in Title 9, Code of the law to the Animal Welfare Act (AWA). This amendment Federal Regulations (CFR), Subpart F, for “other warm- authorized the Secretary of Agriculture to regulate other blooded animals” will be applied. Specific regulations for warmblooded animals when used in research, exhibition, farm animals are currently being considered. or the wholesale pet trade. The Pet Protection Act was passed by Congress as part of An amendment in 1976 (P.L. 94-279) prohibited animal the Food, Agriculture, Conservation, and Trade Act of 1990 fighting ventures and regulated the commercial transporta- (November 18, 1990). It sets specific holding periods for tion of animals. In 1985, the Improved Standards for animals in public or private pounds or shelters and requires Laboratory Animals Act was enacted as part of the Food certification that the holding period has been met. The Security Act and further amended the AWA. These regulations for this Act, proposed on November 15, 1991, were amendments required the Secretary to issue additional in the final approval process at the close of FY 1992. standards for the use of animals in research. In 1990, injunctive relief and pet protection provisions were passed as part of the Food, Agriculture, Conservation, and Trade Act of 1990. The injunctive relief provision authorized the Secretary to seek an injunction to stop a licensed entity from continuing to violate the AWA while charges are pending. The pet protection provision mandates that the Secretary issue additional regulations pertaining to random source dogs and cats. (Random source means “dogs and cats obtained from animal pounds or shelters, auction sales, or from any person who did not breed and raise them on his or her premises.”) Expenditures for FY 1992 APHIS/REAC Headquarters Activities The FY 1992 Animal Welfare program obligated $9,594,000, The assistant deputy administrator for Animal Care super- including $500,000 devoted to funding Regulatory Enforce- vises the inspection field force and the director of the ment activities related to animal welfare. The tabulation Animal Care staff. That staff provides technical support below indicates the AWA expenditures for FY 1992 and and assists in developing program direction, goals, priori- the preceding 2 fiscal years. ties, policies, procedures, and regulations to carry out the Animal Care program effectively and efficiently. The Expenditures for Animal Welfare, FY 1990-92 Animal Care staff serves as the source of the agency’s expertise in the areas of laboratory animals and research Annual expenditures facilities, horse protection, exhibition animals, and animal NY Animal welfare Regulatory enforcement Total dealers. (Millions) (Millions) (Millions) In cooperation with APHIS’ Recruitment and Development 1992 $9.094 $0.5 $9.594 group, the Animal Care staff provides program training for eal $8.967 $0.5 $9.467 Animal Care personnel. The staff also cooperates with 1990 $7.527 NA $7.527 other Federal agencies in enforcing the AWA and in maintaining liaison and working relations with regulated professional groups, industry organizations, humane NA = Prior to FY 1991, Regulatory Enforcement expenditures related to animal welfare were included in the Animal Welfare program. groups, and other concerned groups and individuals. The Regulatory Enforcement staff has the enforcement Organization and Administration of the AWA function for all APHIS programs. This includes, but is not limited to, investigation of violations of the AWA regula- USDA is charged with developing and implementing tions, the documentation of evidence, and the develop- regulations to support the AWA. These regulations, which ment of alleged violation cases for prosecution. Regulatory appear in 9 CFR, Parts 1-3, provide minimum standards for Enforcement personnel work closely with USDA’s Office of the care and handling of covered animals. Included are the General Counsel in the prosecution of violators. requirements for handling, housing, feeding, sanitation, ventilation, shelter from extreme weather, veterinary care, APHIS/REAC Field Activities and separation of species when necessary. Birds, laboratory rats, and laboratory mice are currently excluded from The Animal Care program is regionally administered these regulations, but legal action pending at the end of through sector offices in Annapolis, MD; Minneapolis, MN; FY 1992 may cause their inclusion. Sacramento, CA; Fort Worth, TX; and Tampa, FL. Each sector office is responsible for administering the AWA in Within USDA, APHIS is responsible for administering the the specific States within its jurisdiction. Based at each AWA. The REAC unit of APHIS has direct responsibility sector office is a supervisory veterinary medical officer for administration of this program. REAC was established who manages the Animal Care program and a supervisory within APHIS in 1988 to administer and enforce the AWA investigator who manages the Regulatory Enforcement and the Horse Protection Act. program. Licensing, registration, and investigation of complaints and alleged violations are accomplished by The Animal Care component of APHIS/REAC allows APHIS APHIS/REAC administrative, technical, and clerical employ- to give exclusive attention and visibility to the Animal Care ees also based at the sector offices. The Animal Care field program. Employees of Animal Care devote 100 percent force consists of veterinary medical officers and animal of their efforts to animal care. These personnel are highly care inspectors. Regulatory Enforcement field personnel qualified and have an excellent professional support are investigators who perform compliance investigations. system and communication network. All of these individuals are highly trained, and some have specialized interest Training and expertise in such areas as the care of laboratory animals, zoo animals, and marine mammals. During FY 1992, the Recruitment and Development staff and the Animal Care staff developed and presented 6 The Regulatory Enforcement component of APHIS/REAC formal training courses for 196 field personnel at various brings together the professional investigators of the agency locations across the country. into a single unit. Regulatory enforcement is an integral part of an overall approach to achieving compliance with In FY 1992, 136 REAC personnel completed 1 of 4 training APHIS regulations through sound enforcement and strong courses on dealer recordkeeping, 30 employees completed educational efforts. 1 course on basic animal care, and 30 employees completed 1 course on water quality for marine mammals. The instructors included experts from Federal agencies and the private sector. Also in FY 1992, the Animal Care staff developed and set forth in the regulations. Following the investigation of implemented the Exhibition Animal Internship Program. It an alleged violation, a license may be revoked or sus- provides specialized training for two Animal Care employ- pended by an Administrative Law Judge after notice and ees annually in exhibition-animal husbandry and manage- opportunity for a hearing. Licensing fees for dealers and ment. A field veterinary medical officer participates in a exhibitors are determined by a graduated schedule listed in 13-week program, and an animal care inspector partici- the regulations [9 CFR 2.6(5)(c)]. Dealers pay between $30 pates in a 7-week program. They spend varying amounts and $750, and exhibitors pay between $30 and $300 per of time at zoological institutions working with the staff and year. These fees are deposited as “miscellaneous receipts” studying the operations and management of zoos and in the U.S. Treasury. aquariums. Curriculum development involves coordinated liaison with the member institutions of the American The AWA also requires all carriers, intermediate handlers, Association of Zoological Parks and Aquariums who also exhibitors not subject to licensing, and non-Federal are actively participating in the implementation and further research facilities to register with the Secretary of Agricul- development of the program. This pilot program will be ture. There is no charge to register. completed in FY 1993. Research Facilities Licensing and Registration Research facilities include hospitals, colleges and universi- The AWA regulations require the licensing of animal ties, diagnostic laboratories, and many private firms in the dealers, exhibitors, and operators of animal auction sales pharmaceutical and biotechnology industries. The list where animals regulated under the AWA are sold. includes both Federal and non-Federal research facilities. Licenses are valid unless the licensee terminates the license voluntarily or fails to renew it, or if the license is sus- All research facilities are required to comply with the pended or revoked by an Administrative Law Judge in an AWA’s regulations. Even though Federal facilities are not enforcement proceeding. The Department terminates registered or inspected under the AWA, they are respon- licenses that are not renewed within the time requirements sible for maintaining compliance with the AWA’s regula- Chart 3 Registered Research Facilities Pi¢ WSO Ss) 4,500 4,000 3,500 3,000 2,500 2,000 14,470 1,474 1927 1,500 1,000 500 0 Number of Number of Number of Number of facilities sites inspections reinspections Numbers from WBBS reports